The aim of the study is to assess the accuracy and feasibility of contrast enhanced ultrasonography (CE-US), in the primary diagnosis and relapse during follow up of small bowel CD, compared to MR enterography. Furthermore we attempt to determine…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The disease activity scores at CE-US (qualitative and quantitative), MRE and
ileocolonoscopy and clinical activity score.
Secondary outcome
Not applicable
Background summary
Magnetic resonance enterography/enteroclysis (MRE) and ileocolonoscopy are the
standard procedures in the primary diagnosis and follow-up of inflammatory
disease of the small bowel.
Bowel ultrasound is a non-invasive and inexpensive modality which has also been
proposed for diagnosing small bowel Crohn*s disease, but because of limited
accuracy has not yet been incorporated in the daily practice. Contrast enhanced
ultrasonography with intravenous contrast has been shown to improve the acuracy
of ultrasound in detecting disease activity in patients already known with
small bowel CD.
No studies have yet examined the acuracy and feasibility of CE-US in patients
suspected of having small bowel CD in comparison with MR enterography, and the
correlation of these findings with the level of inflamation assessed by
ileocolonoscopy and histology. Our hypothesis is that contrast enhanced
ultrasonography is just as accurate as MR enterography in the diagnosis of
small bowel Crohn*s disease.
Study objective
The aim of the study is to assess the accuracy and feasibility of contrast
enhanced ultrasonography (CE-US), in the primary diagnosis and relapse during
follow up of small bowel CD, compared to MR enterography. Furthermore we
attempt to determine the correlation between disease severity assessed by
ileocoloscopy and histology compared to the ultrasonographic findings.
Study design
A prospective, cohort study.
Within one week after the confirmation of the diagnosis Crohn's disease
(ileocolonoscopy with biopsies) all patients will receive the CE-US followed by
the magnetic resonance enterography (MRE).
Study burden and risks
The burden for the individual patient, associated with participation to the
study could be related to the period of time spent on the radiology department
for undergoing the CE-US (approximately 45 minutes longer), which will be
performed on the same day with the MRE. Eventual discomfort during the CE-US
could be related to possible adverse reaction of the contrast agent, such as
headache and nausea (2,3%), injection site reactions (1,7%). Furthermore is
there a very small risk for een allergic reaction
Wagnerlaan 55
6800 TA Arnhem
NL
Wagnerlaan 55
6800 TA Arnhem
NL
Listed location countries
Age
Inclusion criteria
- age between 18-65 years old;
- confirmed Crohn*s disease by ileocolonoscopy with biopsies;
- informed consent;
Exclusion criteria
- cardiac failure (acute or chronic NYHA class II -IV) or other heart disease (unstable angina pectoris, recent acute coronary syndrome, severe rhythm disorders), right-to-left cardiac shunts, uncontrolled systemic hypertension, severe pulmonary hypetension and adult respiratory distress syndrome, which contraindicate the use of intravenous contrast during CE-US;
- chronic end stage kidney disease (risk for nephrogenic systemic sclerosis by use of MRI contrast agent: Gadolinium);
- patients having absolute contraindications for the MRI (intracorporal metal clips, neurostimulator, insuline pomp or pacemaker);
- patients with an acute abdomen and indication for surgery;
- pregnancy and lactation;
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-013503-55-NL |
| CCMO | NL28132.091.09 |